Table 1

Study flow chart

Evaluation

Observational Phase

Month

M0

M6 (± 1 M)

M12 (± 2 M)

M24 (± 2 M)

Demographics & Co-morbidity

Inclusion/Exclusion Criteria

X

Patient Identification

X

X

X

X

Date of visit

X

X

X

X

Date of consent

X

Demographics

X

Physical examination

X

X

X

X

Diabetes history

X

Diabetic complications and co-morbidity

X

X

X

X

Pharmacotherapy

X

X

X

X

Laboratory values:

TC, TG, HDL-C, LDL-C

X

X

X

X

Serum-Creatinine, Micro-, Macroalbuminuria

X

X

X

X

CRP

X

X

X

X

Hb_A1c, FPG, PPG

X

X

X

X

Non-drug intervention

X

X

X

X

Hypoglycaemic events

X

X

X

X

Body Weight

Body weight and height

X

X

X

X

Hip and waist circumference

X

X

X

X

EQ-5D, DTSQ

X

X

X

Hypoglycemia Awareness Questionnaire

X

X

X

X

WHO-5

X

X

X

TC, total cholesterol; TG, triglycerides; HDL, high density lipoprotein; LDL, low density lipoprotein; Hb_A1c, glycosylated haemoglobin A1c; CRP, C-reactive protein; FPG, fasting plasma glucose; PPG, post-prandial glucose; EQ-5D, EuroQol-5D; DTSQ, Diabetes Treatment Satisfaction Questionnaire; WHO, World Health Organization

Bramlage et al. Cardiovascular Diabetology 2010 9:53   doi:10.1186/1475-2840-9-53